Use of Immersive Virtual Reality (iVR) for Surgical Planning in Neuroblastoma: A Randomized and Controlled Multicentric Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Surgical time
研究概览
简要总结
Neuroblastoma is one of the most common extracranial solid tumors in children. It originates from cells of the neural crest, and can be located at the adrenal level, or in the sympathetic chains from the neck to the pelvis. Surgery still remains a mainstay part of the treatment and this is particularly challenging when IDRF are present. Adequate surgical planning, based on images such as CT Scans, MRI and/or nuclear medicine is crucial. This project seeks to compare; surgical time, GTR percentage and complications between standard surgical planning with biplanar 2D images vs the use of virtual reality as a planning tool, through the segmentation and post-processing of medical images and the visualization of 3D models with immersive virtual reality glasses (VR). The software that will be used for the segmentation and generation of 3D images will be Materialise Mimics® Innovation Suite and the images can be viewed using the Meta Quest 2® virtual reality glasses and the Materialise Mimics Viewer® software, which sends the processed images to be seen only by the treating surgeon, without patient data.
The study design will be of the type of multicenter clinical trial, controlled and with simple randomization. All patients with a debut diagnosis of neuroblastoma in stage L1, L2 or M who have a surgical indication will be recruited. Surgical time, complications, amount of resection (GTR), surgeon's satisfaction as well as surgical anatomy comprehension will be compared. An invitation to participate will be sent to hospitals around the world.
详细描述
The study design will be a prospective, controlled, multicenter clinical trial with simple randomization, in patients with neuroblastoma in stages L1, L2 and M who require resective surgery. It will be a single-blind study (the patient will not know to which group he/she will be assigned)
There will be two groups, which will be studied in parallel.
- Group A: Surgical planning with iRV.
- Group B: Surgical planning without iRV.
The study group will be A, where the treating surgeon will use iVR, through the use of MetaQuest 2 ® glasses, as part of the surgical planning based on the 2D images of each patient (CT or MRI), and the control group will be B, where only the 2D images will be used for surgical planning.
Randomization will be done through the database software REDCap®, which will assign each patient entering the study to one or another group, when the surgery is indicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients (0-18 years) with neuroblastoma in L1, L2 or M stages (INGRSS) who have surgical indication for resection.
排除标准
- •Patients with relapsed neuroblastoma.
- •Patients with neuroblastoma other than abdominal or pelvic location.
- •Patients with previous surgery for the current diagnosis of neuroblastoma (excluding the biopsy that made the diagnosis).
- •Patients who have undergone laparoscopic surgery.
- •Patients operated on by a surgical team other than the one that usually treats oncology children at your center.
- •Failure to obtain informed consent.
- •Lack of complete medical records.
结局指标
主要结局
Surgical time
时间窗: From date of randomization until three months after surgery
Reduction in surgical time when iVR is used
次要结局
未报告次要终点
